NOTICE: Applications submitted in response
to this Funding Opportunity Announcement (FOA) for Federal assistance must be
submitted electronically through Grants.gov (http://www.grants.gov)
using the SF424 Research and Related (R&R) forms and the SF424 (R&R)
Application Guide.

APPLICATIONS
MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA
must be read in conjunction with the application guidelines included with this
announcement in Grants.gov/Apply
for Grants (hereafter called Grants.gov/Apply).

A
registration process is necessary before submission and applicants are highly
encouraged to start the process at least four (4) weeks prior to the grant
submission date. See Section IV.

Note: Applications submitted for the January 15, 2009 receipt date and thereafter, will use Adobe forms, which will be available in December, 2008 (see NOT-OD-08-117).

Key DatesRelease/Posted
Date: July 15, 2008Opening Date: August 17, 2008 (Earliest date an application may be submitted to
Grants.gov) Letters
of Intent Receipt Date(s):August 17, 2008; December 15,
2008; April 1, 2009NOTE: On-time submission requires that
applications be successfully submitted to Grants.gov no later than 5:00 p.m.
local time (of the applicant institution/organization). Application Due Date(s): September 17, 2008; January 15, 2009; May 1, 2009AIDS Application Due Date(s):Not applicablePeer Review Date(s):February/March
2009; June/July 2009; October/November 2009 Council Review Date(s):May 2009;
October 2009; January 2010Earliest Anticipated Start Date(s):June 2009; November 2009;
February 2010Additional Information To Be
Available Date (Activation Date):Not
ApplicableExpiration Date: May 2, 2009

Due
Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Purpose.The
purpose of this Funding Opportunity Announcement (FOA) is to solicit Small
Business Innovation Research (SBIR) grant applications from small business
concerns (SBCs) for development of new, innovative technologies for
research integrating human social and/or behavioral science with
other disciplines.

Mechanism of Support.This FOA will utilize the SBIR (R43/R44) grant
mechanisms for Phase I, Phase II, and Fast-Track applications and runs in
parallel with a FOA of identical scientific scope, PAR-08-201,
which solicits applications under the Small Business Technology Transfer
(STTR) (R41/R42) grant mechanisms.

Funds Available and
Anticipated Number of Awards. Awards issued under
this FOA are contingent upon the availability of funds and the submission of a
sufficient number of meritorious applications. The
total amount awarded and the number of awards will depend upon the mechanism
numbers, quality, duration, and costs of the applications received.

Budget and Project Period. Phase
I awards normally may not exceed $100,000 total for a period normally not
to exceed 6 months. Phase II awards normally may not exceed $750,000 total
for a period normally not to exceed 2 years. These award levels and
project periods are statutory guidelines, not ceilings. Therefore,
applicants are encouraged to propose a budget and project duration period
that is reasonable and appropriate for completion of the research project.

Eligible Institutions/Organizations: Only
United States SBCs are eligible to submit SBIR applications. A SBC is one
that, on the date of award for both Phase I and Phase II funding
agreements, meets ALL of the criteria as described in Section III.

Eligible Project
Directors/Principal Investigators: Individuals with the skills,
knowledge, and resources necessary to carry out the proposed research are
invited to work with their organization to develop an application for support. Individuals
from underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH support. On an SBIR
application, the PD/PI must have his/her primary employment (more than 50%) with the SBC at the time
of award and for the duration of the project.

Number of PDs/PIs. More than one PD/PI,
(i.e., multiple PDs/PIs), may be designated on the application.

Number of Applications: Applicant SBCs may submit more
than one application, provided each application is scientifically
distinct.

Resubmissions. Applicants may submit a
“resubmission” application, but such application must include an “Introduction”
addressing the previous peer review critique (Summary Statement).

The purpose of this funding opportunity is to
advance the understanding of health through development of innovative new
technologies to facilitate collaborative research integrating social and/or
behavioral scientific disciplines with other disciplines. This announcement
supports applications to develop tools for use in conducting interdisciplinary,
multilevel research that will integrate levels of analysis ranging from
individual (e.g., cellular, biological, physiological, molecular, genetic) to
population levels and all levels in between (e.g., interpersonal, family,
community, social, global). In this FOA, the term “technologies” refers to
such things as research tools, software, equipment or devices eligible for
commercialization that provide opportunities for moving interdisciplinary
research forward.

Applications must involve collaborative teams in
the development of the proposed technologies. These teams will be composed of
at least one or more social and/or behavioral scientists engaged with other
specialists in product development. For the purposes of this FOA, behavioral
and social sciences research uses the NIH Office of Behavioral and Social
Sciences definition, found at: http://obssr.od.nih.gov/Content/About_OBSSR/BSSR_Definition/.
Supported project development can advance and integrate social and/or
behavioral science with other discipline(s) as diverse as atmospheric science,
biochemistry, biology, biomedicine, computational science, computer science,
economics, engineering, geography, genetics, informatics/information science,
mathematics, physics, physiology, and robotics. Note that this list is meant
to be illustrative, not all-inclusive.

Background

In 2007 NIH issued RFA RM-07-004 in response to the ongoing need for behavioral and social science involvement
in interdisciplinary health research. The focus was on the creation of research
tools (measures, methodologies and technologies) supporting integration of
human social and/or behavioral science with other disciplines across varying
levels of analysis. This earlier opportunity was part of the NIH Roadmap for
Medical Research; all NIH Institutes and Centers (IC’s) participate in Roadmap
initiatives (for more information about the NIH Roadmap Initiative, please
visit: http://nihroadmap.nih.gov).

Building on that effort, this FOA utilizes the
SBIR mechanisms (R43/R44) and departs from the earlier Roadmap initiative in
several important ways. First, all applications must meet requirements for
product development and small business concern eligibility criteria relevant to
SBIR. Second, in terms of topical focus, this FOA emphasizes funding for
projects to develop new technologies rather than methodological innovations.
However, unlike SBIR applications that might fall under an omnibus
solicitation, the research utility of the technological innovation should be
paramount, while any treatment or assistive application of the device or
technology might be a complement to the research function.

SCIENTIFIC RATIONALE FOR INTERDISCIPLINARY,
MULTI-LEVEL APPROACHES

Behavioral and social sciences have offered
significant, fundamental insights into the comprehensive understanding of human
health and diseases, including knowledge of disease etiology, prevention, and
treatment, and of factors critical to the promotion of health and well-being.
Integrating scientific insights and technologies gleaned from behavioral and
social sciences with approaches from other scientific disciplines offers the
promise of further advancing the public health mission of the NIH.

Much behavioral research on health assumes that
individual action is an important vehicle for understanding and changing social
and health behaviors, but acknowledges that individuals are heavily influenced
by actions occurring at other levels: from genomic, molecular, cellular, and
organ systems, to family, workplace and community levels, to state, national,
and global socioeconomic, environmental and geopolitical factors. Each
additional layer of action requires more complex models. To better understand
the relationships among these multiple levels, and to more fully elucidate
their interactions, more sophisticated research tools are needed.

Distinct disciplinary perspectives contribute
significant sources of strength to the overall research enterprise because each
discipline has its own intellectual history, experimental and analytic
approaches, and theoretical context that produce a unique way of thinking about
a problem. Nevertheless, with ever-expanding scientific knowledge and improved
capabilities, increasingly sophisticated questions arise. Answering these
questions often requires the convergence of perspectives from multiple
disciplines to address challenging and complex problems in biomedical and
behavioral research (such as obesity, diabetes, cardiovascular and
cerebrovascular disease, HIV/AIDS, substance abuse, mental illness, etc.) in a
comprehensive and effective way. Complex problems may require expertise from a
variety of disciplines and the integration of data at multiple levels to be
addressed adequately. The purpose of this FOA is to address this need.

Participating ICs invite qualified SBCs to
submit novel grant applications designed to develop innovative new technologies
that support interdisciplinary integration of human social and/or behavioral
research with research from other disciplines. Applicants are strongly
encouraged to demonstrate how research tools can promote research integrating
multiple levels of analysis ranging anywhere from subcellular micro-levels to
human populations in advancing critical areas of health.

In line with the spirit of interdisciplinary
research, applications must involve research teams. Teams must include
behavioral and/or social scientists in addition to technicians and scientists
with other backgrounds. Applicants should provide a strong and compelling
rationale for how teams are constituted and how they expect the group to work
synergistically.

Examples of SBC innovations sought by this FOA
include, but are not limited to, those described below. Again, all examples are
presumed to involve collaborative teams and approaches (including at least one
behavioral or social scientist developing a technology apt for
interdisciplinary research involving a social/behavioral approach), and to be
relevant to health research.

Technologies that facilitate the use
of nonlinear analytic methods by behavioral and social scientists e.g., systems
dynamic modeling, agent-based modeling, and other simulation techniques.

Technologies that enhance analytical
power in the application of the mathematical modeling of behavior (e.g.,
computer applications that broaden access to mathematical models for
understanding systems that govern health behavior over time and across lifespan
development).

Technologies that improve or
facilitate integration and analysis of large data sets, (e.g., integrating
behavioral data with genomic or ecologic data, or data resulting from frequent
observational or streaming data such as from ecological momentary assessment).

Technologies that
improve the convenience and accurate measurement of behavioral phenomena in “real-world” settings (for example unobtrusive, user-friendly, wearable devices
and those utilizing wireless monitoring technology) and at the moment when the
phenomena of interest actually occurs (i.e., directed to ecological momentary
assessment) while reducing participant and research staff burden. Such technologies would decrease research
participants’ reactivity to situational demands resulting in more accurate
data. Target behaviors for such technologies include, but are not limited to
energy balance (i.e., real-time calculation of energy consumed versus energy
expended), physical activity, dietary intake, smoking (i.e., where and when it
occurs along with quantity smoked and contextual information), and medication
adherence.

Technologies that enhance
measurement of co-occurring biological and behavioral
processes.

Technologies that enable
simultaneous measurement of behavioral and biological variables utilizing
existing technologies, including, but not limited to, imaging probes, more
sensitive noninvasive techniques, robotics or supercomputing networks. For
example, a tool that captures glucose levels,
activity levels, eating behavior and insulin dosing in real-time in
diabetic patients and uses this data as input for metabolism simulation and prediction. The development of
such a technology might later lead to the development
of interventional technologies with ability to warn patient/caregiver of
upcoming danger.

Technologies that measure and/or capture diagnostic indicators of behavioral and/or
psychiatric disorders, or of behavioral phenotypes. For example,
technologies that combine behavioral, emotional,
cognitive and/or social indices at varying levels of analysis and across
development, developed to accompany marketable detection tests of biomarkers,
for use in assessment in interdisciplinary research, such as genetics research.

Technologies that facilitate the
study of gene/environment interactions on a large scale, especially those that
explore the bidirectional nature of these relationships (i.e., not only how
physical, behavioral or social environments impact gene expression and the
biological mechanisms that mediate these relationships, but also how genes
impact selection to particular environments and the underlying behavioral
mechanisms that may mediate such relationships).

Technologies that facilitate
visualization of data integration across levels of analysis and time.

Technologies that increase
availability of systems dynamic modeling tools, agent-based modeling tools, or tools designed for other modeling or simulation methodologies.

Technologies
that facilitate the integration of social and behavioral data with data from other areas
(e.g., genetics, biology, economics, media campaigns, policy),
particularly where the technology results in integrated data that can readily
be input into computational models.

Technologies that improve the
capture and analysis of social network data, including improvements to social
networking analysis tools that would enable integration of social network data
with disease data. For example, integrating the use of assays for
identification of recent HIV infection [RNA PCR, STARHS] with social network
and ethnographic techniques for identifying the context of recent infection
(e.g., venues where anonymous/casual contacts meet). Such tools could further
the current understanding of demographic structure and/or social networks to
shed light on the diffusion of infectious agents and guide the design and
implementation of social policies aimed at preventing or reducing epidemics.

Technologies that facilitate
bio-behavioral research on initiation and maintenance of long term behavior
change and patient adherence to medical treatment (e.g., technology that
enables long term monitoring of smokers, obese persons, or patients with chronic
disorders with respect to their adherence to smoking cessation programs,
dietary regimens, prescription medications, or other medical recommendations
and health-related behaviors).

Technologies
that can be used by behavioral and social scientists to facilitate the
research, development and evaluation of effective and user-friendly
robot-assisted therapy (for both in-clinic and in-home uses). For example,
technologies that allow objective and accurate measurement and calibration of
the intensity of task specific training (behavioral science), or technologies
that capture interpersonal engagement and self-management of activities (social
science). Also included are technologies that detect and capture novel and
comprehensive user activity along with strategies for interpreting the meaning
of the data thus captured, so that it can be incorporated into the development
of new and innovative socially assistive robotics therapy for monitoring and
coaching users toward personalized and optimized physical or cognitive
rehabilitation regimens.

Technologies that improve or
facilitate information visualization via open source software to integrate data
at multiple levels of analysis and/or facilitate the analysis of large data
sets.

Technology to integrate video data
with large scale survey data to provide access that protects participant
confidentiality and permits qualified parties with appropriate permissions to
analyze this data. Such technology would illuminate the details of human
interaction and context and would require content experts in the social and
behavioral sciences, along with information technologists, computer engineers,
and videographers.

This funding opportunity
will use the Small Business Innovation Research (SBIR [R43/R44] grant
mechanisms.Applications may be submitted
for support as Phase I, Phase II, or Fast-Track grants as described in the
SF424 (R&R) SBIR/STTR Application Guide. Phase II Competing Renewal
applications are not accepted under this funding opportunity announcement.

Small
business concerns that have received a Phase I SBIR grant may apply for Phase
II funding of that project. The Phase II must be a logical extension of the
Phase I research but not necessarily as a Phase I project supported in response
to this funding opportunity. Phase II applications will compete with all SBIR
applications and will be reviewed according to the customary peer review
procedures

The
applicant small business concern (SBC) will be solely responsible for planning,
directing, and executing the proposed project.

This
funding opportunity uses “Just-in-Time” information concepts. The modular
budget format is not accepted for SBIR grant applications. Applicants must
complete and submit budget requests using the SF424 Research and Related
(R&R) Budget component found in the application package attached to this
FOA in Grants.gov/Apply.

2. Funds Available

Awards
issued under this FOA are contingent upon the availability of funds and the
submission of a sufficient number of meritorious applications. The total amount awarded and the number of awards will
depend upon the quality, duration, and costs of the applications received.

The SF424
(R&R) SBIR/STTR Application Guide indicates the statutory guidelines of
funding support and project duration periods for Phase I and Phase II SBIR
awards. Phase I awards normally may not exceed $100,000 total for a period
normally not to exceed 6 months. Phase II awards normally may not exceed
$750,000 total for a period normally not to exceed 2 years. These award levels
and project periods are statutory guidelines, not ceilings. Therefore,
applicants are encouraged to propose a budget and project duration period that
is reasonable and appropriate for completion of the research project. Applicants
are strongly encouraged to contact the appropriate research Program Officer
regarding budgets as well as application content.

Facilities
and Administrative (F&A) costs requested by consortium participants are not
included in the direct cost limitation. See NOT-OD-05-004.

The
decision of whether to apply for a grant with a single PD/PI or multiple
PDs/PIs grant is the responsibility of the investigators and applicant
organizations and should be determined by the scientific goals of the project.
Applications for grants with multiple PDs/PIs will require additional
information, as outlined in the instructions below. The NIH review criteria for
approach, investigators, and environment have been modified to accommodate
applications involving either a single PD/PI or multiple PDs/PIs. When
considering the multiple PD/PI option, please be aware that the structure and
governance of the PD/PI leadership team as well as the knowledge, skills and experience
of the individual PDs/PIs will be factored into the assessment of the overall
scientific merit of the application. Multiple PDs/PIs on a project share the
authority and responsibility for leading and directing the project,
intellectually and logistically. Each PD/PI is responsible and accountable
to the grantee organization, or, as appropriate, to a collaborating
organization, for the proper conduct of the project or program, including the
submission of required reports. For further information on multiple PDs/PIs,
please seehttp://grants.nih.gov/grants/multi_pi.

Under the
SBIR program, for both Phase I and Phase II, the primary employment of the PD/PI must be with the small business concern at the time of award and
during the conduct of the proposed project. For projects with
multiple PD/PIs, at least one must meet the primary employment requirement.
That individual will serve as the Contact PD/PI. Primary employment means that
more than one half of the PD/PI’s time is spent in the employ of the small
business concern. Primary employment with a
small business concern precludes full-time employment at another organization. Occasionally, deviations from this requirement may occur. Such deviations must
be approved in writing by the grants management officer after consultation with
the NIH SBIR/STTR Program Coordinator.

When the
proposed PD/PI clearly does not have sufficient qualifications to assume this
role, the application is not likely to receive a favorable evaluation.

If the
application has the likelihood for funding, the awarding component will require
documentation to verify the eligibility of the Contact PD/PI, if at the time of
submission of the application, the Contact PD/PI is a less-than-full-time
employee of the small business concern, is concurrently employed by another
organization, or gives the appearance of being concurrently employed by another
organization, whether for a paid or unpaid position.

If the
Contact PD/PI is employed or appears to be employed by an organization other
than the applicant organization in a capacity such as Research Fellow,
Consultant, Adjunct Professor, Clinical Professor, Clinical Research Professor,
or Associate, a letter must be provided by each employing organization
confirming that, if an SBIR grant is awarded to the applicant small business
concern, the Contact PD/PI is or will become a less-than-half-time employee of
such organization and will remain so for the duration of the SBIR project. If the
Contact PD/PI is employed by a university, such a letter must be provided by
the Dean's office or equivalent; for other organizations, the letter must be
signed by a corporate official.

All current
employment and all other appointments of the Contact PD/PI must be identified
in his or her “Biographical Sketch” required as part of the application. Be
certain that correct beginning and ending dates are indicated for each
employment record listed.

Applicants may submit more than one application, provided
each application is scientifically distinct.

Applicants may not simultaneously submit
identical/essentially identical applications under both this SBIR funding
opportunity and any other HHS FOA, including the current SBIR and STTR Parent
FOAs. The NIH
will accept as many different applications as the applicant organization
chooses. However, the NIH will not accept similar grant applications with
essentially the same research focus from the same applicant organization. This
includes derivative or multiple applications that propose to develop a single
product, process or service that, with non-substantive modifications, can be
applied to a variety of purposes. Likewise, identical or essentially identical
grant applications submitted by different organizations will not be accepted. Applicant
organizations should ascertain and assure that the materials they are
submitting on behalf of the principal investigator are the original work of the
principal investigator and have not been used elsewhere in the preparation and
submission of a similar grant application. Applications to the NIH are grouped
by scientific discipline for review by individual Scientific Review Groups and
not by disease or disease state. The reviewers can thus easily identify
multiple grant applications for essentially the same project. In these cases,
application processing may be delayed or the application(s) may be returned to
the applicant without review.

It is
unlawful to enter into contracts or grants requiring essentially equivalent
work or effort. “Essentially equivalent work or effort” occurs when (1)
substantially the same research is proposed for funding in more than one
contract proposal or grant application submitted to the same Federal agency;
(2) substantially the same research is submitted to two or more different
Federal agencies for review and funding consideration; or (3) a specific
research objective and the research design for accomplishing an objective are
the same or closely related in two or more proposals or awards, regardless of
the funding source. If there is any question concerning essentially equivalent
work or effort, it must be disclosed to the soliciting agency or agencies
before award.

Only one Phase II award may be made for a single SBIR/STTR
project. Phase II Competing Renewal grant applications are not accepted under
this PAR.

You
may submit a Phase II application either before or after expiration of the
Phase I budget period, unless you elect to submit a Phase I and Phase II
application concurrently under the Fast-Track procedure. To maintain
eligibility to seek Phase II support, a Phase I grantee organization should
submit a Phase II application within the first six receipt dates following the
expiration of the Phase I budget period.

The applicant SBC must present a team that includes a
qualified technical or scientific specialist relevant to the technology being
developed, working with at least one social or behavioral scientist on the
proposed project. The strongest applications will justify the composition of
research and development teams, and explain the roles of the different parties
in technology development.

Section
IV. Application and Submission Information

To
download a SF424 (R&R) Application Package and SF424 (R&R) SBIR/STTR
Application Guide for completing the SF424 (R&R) forms for this FOA, use
the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow
the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

The individual(s) designated as PD/PIs
on the application must also be registered in the NIH eRA Commonsand be assigned the PI role in the eRA Commons prior to the submission of the application. It is not necessary for PDs/PIs
to register with Grants.gov.

Each
PD/PI must hold a PD/PI account in the Commons. Applicants should not
share a Commons account for both an Authorized Organization
Representative/Signing Official (AOR/SO) role and a PD/PI role; however,
if they have both a PD/PI role and an Internet Assisted Review (IAR) role,
both roles should exist under one Commons account.

When
multiple PDs/PIs are proposed, all PDs/PIs at the applicant organization
must be affiliated with that organization. When PDs/PIs are located
at another institution, only the contact PI (the PI named on the SF424
(R&R) Cover) must be affiliated with the applicant small business
concern; other PD/PIs need not be affiliated with the applicant
organization, but must be affiliated with their own organization to be
able to access the Commons.

This
registration/affiliation must be done by the AOR/SO or their designee who
is already registered in the Commons.

To affiliate the PD/PI with the applicant small business
concern:

PD/PI gives Commons user ID and
email address to the administrator of the applicant
organization/institution. (The email address must be the one that is
contained in the Personal Profile for the PD/PI.)

Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the
Accounts Administrator.)

Administrator selects
"Administration" tab and then "Accounts" tab.

Administrator selects "Create
Affiliation" tab.

Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."

Both the
PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an
Individual DUNS and CCR registration, that particular DUNS number and CCR
registration are for the individual reviewer only. These are different than any
DUNS number and CCR registration used by an applicant organization. Individual
DUNS and CCR registration should be used only for the purposes of personal
reimbursement and should not be used on any grant applications submitted to the
Federal Government.

Several of the steps of the registration process could
take four weeks or more. Therefore, applicants should immediately check with
their business official to determine whether their institution is already
registered in both Grants.gov and the Commons. The NIH will accept
electronic applications only from organizations that have completed all
necessary registrations.

1. Request Application Information

Applicants must
download the SF424 (R&R) application forms and SF424 (R&R) SBIR/STTR
Application Guide for this FOA using the “Apply for Grant Electronically”
button in this FOA or through Grants.gov/Apply.

Note: Only the forms package directly attached to a
specific FOA can be used. You will not be able to use any other SF424 (R&R)
forms (e.g., sample forms, forms from another FOA), although some of the
"Attachment" files may be useable for more than one FOA.

Prepare all SBIR
applications using the SF424 (R&R) application forms and in accordance with
the SF424 (R&R) SBIR/STTR Application Guide.

The SF424 (R&R)
SBIR/STTR Application Guide is critical to submitting a complete and accurate
application to NIH. There are fields within the SF424 (R&R) application
components that, although not marked as mandatory, are required by NIH (e.g.,
the “Credential” log-in field of the “Research & Related Senior/Key Person
Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Failure
to include this data field will cause the application to be rejected.

The SF424 (R&R)
application has several components. Some components are required, others are
optional. The forms package associated with this FOA in Grants.gov/APPLYincludes all applicable components, required and optional. A completed
application in response to this FOA includes the data in the following
components:

When
multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the
"Contact” PI, who will be responsible for all communication between the
PDs/PIs and the NIH, for assembling the application materials outlined below,
and for coordinating progress reports for the project. The contact PD/PI must
meet all eligibility requirements for PD/PI status in the same way as other
PDs/PIs, but has no other special roles or responsibilities within the project
team beyond those mentioned above.

Information
for the Contact PD/PI should be entered in item 15 of the SF424 (R&R) Cover
component. All other PDs/PIs should be listed in the Research &
Related Senior/Key Person component and assigned the project role of
“PD/PI.” Please remember that all PDs/PIs must be registered in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the
“Credential” field of the Research & Related Senior/Key Person
component. Failure to include this data field will cause the application
to be rejected.

All projects
proposing Multiple PDs/PIs will be required to include a new section describing
the leadership plan approach for the proposed project.

Multiple
PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new
section of the research plan, entitled “Multiple PD/PI Leadership Plan”
[Section 14 of the Research Plan Component in the SF424 (R&R)], must be
included. A rationale for choosing a multiple PD/PI approach should be
described. The governance and organizational structure of the leadership team
and the research project should be described, and should include communication
plans, process for making decisions on scientific direction, and procedures for
resolving conflicts. The roles and administrative, technical, and scientific
responsibilities for the project or program should be delineated for the
PDs/PIs and other collaborators.

If
budget allocation is planned, the distribution of resources to specific
components of the project or the individual PDs/PIs should be delineated in the
Leadership Plan. In the event of an award, the requested allocations may be
reflected in a footnote on the Notice of Award (NoA).

Prospective
applicants are asked to submit a letter of intent that includes the following
information:

Descriptive title of proposed research.

Name, address, and telephone number of the
PD(s)/PI(s).

Names of other key personnel.

Participating institutions.

Number and title of this funding opportunity.

Although
a letter of intent is not required, is not binding, and does not enter into the
review of a subsequent application, the information that it contains allows IC
staff to estimate the potential review workload and plan the review.

Applications may be submitted on or after the opening date and must be successfully
received by Grants.gov no later than 5:00 p.m. local time (of the
applicant institution/organization) on the application due date(s). (See Section IV.3.A. for all dates.) If an application
is not submitted by the receipt date(s) and time, the application may be
delayed in the review process or not reviewed.

Once an application package has been successfully
submitted through Grants.gov, any errors have been addressed, and the assembled
application has been created in the eRA Commons, the PD/PI and the
Authorized Organization Representative/Signing Official (AOR/SO) have two
weekdays (Monday – Friday, excluding Federal holidays) to view the application
image to determine if any further action is necessary.

If everything is acceptable, no
further action is necessary. The application will automatically
move forward to the Division of Receipt and Referral in the Center for
Scientific Review for processing after two weekdays, excluding Federal holidays.

Prior to the submission deadline, the
AOR/SO can “Reject” the assembled application and submit a
changed/corrected application within the two-day viewing window. This
option should be used if it is determined that some part of the
application was lost or did not transfer correctly during the submission
process, the AOR/SO will have the option to “Reject” the application and
submit a Changed/Corrected application. In
these cases, please contact the eRA Help Desk to ensure that the issues
are addressed and corrected. Once rejected, applicants should follow the
instructions for correcting errors in Section 2.12, including the
requirement for cover letters on late applications. The
“Reject” feature should also be used if you determine that warnings are
applicable to your application and need to be addressed now. Remember,
warnings do not stop further application processing. If an application
submission results in warnings (but no errors), it will automatically move
forward after two business days if no action is taken. Some warnings may
need to be addressed later in the process.

If the two-day window falls after
the submission deadline, the AOR/SO will have the option to “Reject” the
application if, due to an eRA Commons or Grants.gov system issue, the
application does not correctly reflect the submitted application package
(e.g., some part of the application was lost or didn’t transfer correctly
during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm
the system error, document the issue, and determine the best course of
action. NIH will not penalize the applicant for an eRA Commons or Grants.gov system issue.

If the AOR/SO chooses to “Reject”
the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be
submitted but it will be subject to the NIH
late policy guidelines and may not be accepted. The reason for this
delay should be explained in the cover letter attachment.

Both the AOR/SO and PD/PI will
receive e-mail notifications when the application is rejected or the
application automatically moves forward in the process after two days.

Upon
receipt, applications will be evaluated for completeness by the Center for
Scientific Review (CSR). Incomplete applications will not be reviewed.

There
will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives
the Grants.gov acknowledgments. The AOR and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific
Review Group is also in the Commons.

Note: Since email can be
unreliable, it is the responsibility of the applicant to check periodically on
their application status in the Commons.

The
NIH will not accept any application in response to this FOA that is essentially
the same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of an application already reviewed with substantial changes, but
such application must include an Introduction addressing the previous critique.
Note such an application is considered a resubmission.

All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH
Grants Policy Statement.

Pre-award costs are allowable. A
grantee may, at its own risk and without NIH prior approval, incur obligations
and expenditures to cover costs up to 90 days before the beginning date of the
initial budget period of a new or competing renewal award if such costs: are
necessary to conduct the project, and would be allowable under the grant, if
awarded, without NIH prior approval. If specific expenditures would otherwise
require prior approval, the grantee must obtain NIH approval before incurring
the cost. NIH prior approval is required for any costs to be incurred more than
90 days before the beginning date of the initial budget period of a new or
competing renewal award.

The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See the NIH
Grants Policy Statement.

The applicant organization must
include its DUNS number in its Organization Profile in the eRA Commons. This
DUNS number must match the DUNS number provided at CCR registration with
Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic
Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Page
limitations of the PHS398 Research Plan component must be followed as outlined
in the SF424 (R&R) Application Guide. While each section of the Research
Plan component needs to be uploaded separately as a PDF attachment, applicants
are encouraged to construct the Research Plan component as a single document,
separating sections into distinct PDF attachments just before uploading the
files. This approach will enable applicants to better monitor formatting
requirements such as page limits. All attachments must be provided to NIH in
PDF format, filenames must be included with no spaces or special characters,
and a .pdf extension must be used.

All application instructions outlined in the SF424
(R&R) SBIR/STTR Application Guide are to be followed, incorporating
"Just-in-Time" information concepts, with the following
requirements.

SBIR
Phase I applications:

Although
preliminary data are not required, they may be included.

Items
2-5 of the Research Plan component may not exceed 15 pages, including tables, graphs, figures, diagrams,
and charts.

The Biographical Sketch is limited
to a maximum of 4 pages for
each senior/key person. (This includes the table at the top of the first page).

There is no further
limitation on the total number of pages for the entire Phase I application;
however, applicants are encouraged to be succinct.

SBIR
Phase II applications:

Items 2-5 of the Research Plan
component may not exceed 25 pages, including tables, graphs, figures, diagrams,
and charts.

The Biographical Sketch is limited
to a maximum of four (4) pages
for each senior/key person. (This includes the table at the top of the first
page.)

The Phase II application must
present a Commercialization Plan (maximum 15 pages) that addresses specific
points as described in the SF424 (R&R) SBIR/STTR Application Guide and the
SBIR/STTR Information component.

There is no further limitation on
the total number of pages for the entire Phase II application; however,
applicants are encouraged to be succinct.

SBIR
Fast-Track applications:

The NIH Fast-Track application is a
single application consisting of Phase I and Phase II activities. See Section
1.3.2., “Fast-Track Applications,” of the SF424 (R&R) SBIR/STTR Application
Guide.

The Phase I portion of a Fast-Track
must specify clear, measurable goals (milestones) that should be achieved prior
to initiating Phase II work.

The Fast-Track application must
present a Commercialization Plan (maximum 15 pages) that addresses specific points
as described in the SF424 (R&R) SBIR/STTR Application Guide.

Items 2-5 of the Research Plan
component may not exceed 25 pages. That is, the combined Phase I and Phase II
plans for Fast-Track applications (for Items 2-5) must be contained within the
25-page limitation.

Resubmissions:

Resubmissions must include an Introduction addressing the
previous peer review critique (Summary Statement).

Introductions are limited to one page for Phase I and three pages
for Phase II and Fast Track submissions.

Warning: Please be sure that you observe the total
cost, project period, and page number limitations specified above for this FOA.
Application processing may be delayed or the application may be rejected if it
does not comply with these requirements.

Do not use the Appendix to circumvent the page
limitations of the Research Plan component. An application that does not
observe the required page limitations may be delayed in the review process. Phase
I SBIR/STTR Appendix materials are not permitted unless specifically requested
by NIH.

Resource Sharing
Plan(s)

NIH
considers the sharing of unique research resources developed through
NIH-sponsored research an important means to enhance the value and further the
advancement of the research. When resources have been developed with NIH funds
and the associated research findings published or provided to NIH, it is
important that they be made readily available for research purposes to
qualified individuals within the scientific community. If the final data/resources are not amenable to sharing,
this must be explained in the Resource Sharing section of the application (see http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm).

(a) (a) Data Sharing
Plan: Applicants requesting $500,000 or more in direct costs in any year
must include a brief one paragraph description of how final research data will
be shared, or explain why data sharing is not possible. The specific nature of
the data to be collected will determine whether or not the final data set may
be shared. If the final data are not amenable to sharing (for example human
subject concerns, the Small Business Act provisions, etc.) this must be
explained in the application.

The precise content of the data-sharing plan will vary,
depending on the data being collected and how the investigator is planning to
share the data. Applicants who are planning to share data may wish to describe
briefly the expected schedule for data sharing, the format of the final
dataset, the documentation to be provided, whether or not any analytic tools
also will be provided, whether or not a data-sharing agreement will be required
and, if so, a brief description of such an agreement (including the criteria
for deciding who can receive the data and whether or not any conditions will be
placed on their use), and the mode of data sharing (e.g., under their own
auspices by mailing a disk or posting data on their institutional or personal Web
site, through a data archive or enclave). Investigators choosing to share under
their own auspices may wish to enter into a data-sharing agreement. References
to data sharing may also be appropriate in other sections of the application.

(b) Sharing Model Organisms: Regardless of
the amount requested, all applications where the development of model organisms
is anticipated are expectedto include a description of a
specific plan for sharing and distributing unique model organisms and related
resources, or state appropriate reasons why such sharing is restricted or not
possible. See Sharing
Model Organisms Policy, and NIH
Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested,
applicants seeking funding for a genome-wide association study are expected
to provide a plan for submission of GWAS data to the NIH-designatedGWAS data repository, or provide an appropriate explanation why submission to the repository is
not possible. A genome-wide association study is defined as any study of
genetic variation across the entire genome that is designed to identify genetic
associations with observable traits (e.g., blood pressure or weight) or the
presence or absence of a disease or condition. For further information
see Policy for Sharing of Data Obtained in NIH Supported or Conducted
Genome-Wide Association Studies (go to NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.)

Section
V. Application Review Information

1. Criteria (Update: Enhanced review criteria have been issued for the evaluation of research applications received for potential FY2010 funding and thereafter - see NOT-OD-09-025).

Only the review
criteria described below will be considered in the review process.

2.
Review and Selection Process

Applications that are complete will be
evaluated for scientific and technical merit by (an) appropriate scientific
review group(s) in accordance with NIH peer review
procedures (http://grants1.nih.gov/grants/peer/) using the review criteria stated below. Applications submitted for this funding opportunity will be assigned
on the basis of established PHS referral guidelines to the ICs for funding
consideration.

As
part of the initial merit review, all applications will:

Undergo a
selection process in which only those applications deemed to have the
highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score;

Receive a
written critique; and

Receive a
second level of review by the appropriate national advisory council or
board.

Applications
submitted in response to this FOA will compete for available funds with all
other recommended applications submitted in response to this FOA. The following will be
considered in making funding decisions:

Scientific
merit of the proposed project as determined by peer review.

Availability
of funds.

Relevance
of the proposed project to program priorities.

The
goals of NIH supported research are to advance our understanding of biological
systems, to improve the control of disease, and to enhance health. In their written
critiques, reviewers will be asked to comment on each of the following criteria
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. Each of these criteria will
be addressed and considered in assigning the overall score, and weighted as
appropriate for each application. Note that an application does not need to be
strong in all categories to be judged likely to have major scientific impact
and thus deserve a meritorious priority score. Note that an application does
not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a meritorious priority score.

Applicants should include information in relevant sections of the
grant application that addresses the questions for each review criterion below.

All SBIR Applications

Significance: Does the proposed project have commercial potential to lead to a marketable
product, process or service? Does this study address an important problem? What
may be the anticipated commercial and societal benefits that may be derived
from the proposed research? If the aims of the application are achieved, how
will scientific knowledge or clinical practice be advanced? What will be the
effect of these studies on the concepts, methods, technologies, treatments,
services, or preventative interventions that drive this field? Does the
application lead to enabling technologies (e.g., instrumentation, software) for
further discoveries? Will the technology have a competitive advantage over
existing/alternate technologies that can meet the market needs?

Approach: Are
the conceptual or clinical framework, design, methods, and analyses adequately
developed, well-integrated, and appropriate to the aims of the project? Is the
proposed plan a sound approach for establishing technical and commercial
feasibility? Are the milestones and evaluation procedures appropriate? Does the
applicant acknowledge potential problem areas and consider alternative tactics?
For applications designating multiple PD/PIs, is the leadership approach,
including he designated roles and responsibilities governance, and
organizational structure, consistent with and justified by the aims of the
project and the expertise of each of the PD/PIs? Is a collaborative
team that includes a social or behavioral scientist and another technical
expert or scientist specified?

Innovation: Is
the project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?

Investigator(s): Are the PD/PI(s) and other key personnel appropriately
trained and well suited to carry out this work? Is the work proposed
appropriate to the experience level of the PD/PI(s) and other researchers,
including consultants and subcontractors (if any)? Do the PD/PIs and
investigative team bring complementary and integrated expertise to the project
(if applicable)? Are the relationships of the key personnel to the small
business and to other institutions appropriate for the work proposed?

Environment: Do(es) the scientific and technological environment in which the work will be
done contribute to the probability of success? Do the proposed studies benefit
from unique features of the scientific environment, or subject populations, or
employ useful collaborative arrangements? Is there evidence of institutional
support? Is there sufficient access to resources (e.g., equipment, facilities)?

Phase
II Applications

In
addition to the above review criteria:

1. How well
did the applicant demonstrate progress toward meeting the Phase I objectives,
demonstrating feasibility, and providing a solid foundation for the proposed
Phase II activity?

2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and
the SBIR/STTR Information component?

3. Does the
project carry a high degree of commercial potential, as described in the
Commercialization Plan?

Phase
I/Phase II Fast-Track Application Review Criteria

For
Phase I/Phase II Fast Track applications, the following criteria also will be
applied:

1. Does the
Phase I application specify clear, appropriate, measurable goals (milestones)
that should be achieved prior to initiating Phase II?

2. Did the
applicant submit a concise Commercialization Plan that adequately addresses the
specific areas described in the SF424 (R&R) SBIR/STTR Application Guide and
the SBIR/STTR Information component?

3.
To what extent was the applicant able to obtain letters of interest, additional
funding commitments, and/or resources from the private sector or non-SBIR/STTR
funding sources that would enhance the likelihood for commercialization?

4. Does the
project carry a high degree of commercial potential, as described in the
Commercialization Plan?

Phase I and
Phase II Fast-Track applications that satisfy all of the review criteria will
receive a single rating.

For
Fast-Track applications, the Phase II portion may not be funded until a Phase I
final report and other documents necessary for continuation have been received
and assessed by program staff that the Phase I milestones have been
successfully achieved. Items 2-5 of the Research Plan may not exceed 25 pages.
That is, the combined Phase I and Phase II plans for a Fast-Track application
(for Items 2-5) must be contained within the 25-page limitation.

2.A. Additional
Review Criteria:

In addition to the
above criteria, the following items will continue to be considered in the
determination of scientific merit and the rating:

Resubmission
Applications: Are
the responses to comments from the previous scientific review group adequate?
Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human
subjects and protections from research risk relating to their participation in
the proposed research will be assessed. See item 6 of the Research Plan
component of the SF424 (R&R).

Inclusion of Women, Minorities and
Children in Research: The adequacy of plans to include subjects from both
genders, all racial and ethnic groups (and subgroups), and children as
appropriate for the scientific goals of the research will be assessed. Plans
for the recruitment and retention of subjects will also be evaluated. See item
7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in
Research: If vertebrate animals are to
be used in the project, the five items described under item 11 of the Research
Plan component of the SF424 (R&R) will be assessed.

Biohazards: If materials or procedures are proposed that are
potentially hazardous to research personnel and/or the environment, determine
if the proposed protection is adequate.

2.B. Additional Review
Considerations

Budget and Period of
Support: The
reasonableness of the proposed budget and the appropriateness of the requested
period of support in relation to the proposed research may be assessed by the
reviewers. The priority score should not be affected
by the evaluation of the budget.

2.C. Resource Sharing
Plan(s)

When relevant, reviewers will be instructed to comment
on the reasonableness of the following Resource Sharing Plans, or the rationale
for not sharing the following types of resources. However, reviewers will not
factor the proposed resource sharing plan(s) into the determination of
scientific merit or priority score, unless noted otherwise in the FOA. Program
staff within the IC will be responsible for monitoring the resource sharing.

Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Section
IV.5., “Funding Restrictions.”

A
formal notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the NoA will be generated via email notification from the awarding
component to the grantee business official.

We
encourage your inquiries concerning this funding opportunity and welcome the
opportunity to answer questions from potential applicants. Inquiries may fall
into three areas: scientific/research, peer review, and financial or grants
management issues:

Human Subjects
Protection:Federal
regulations (45 CFR 46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety
Monitoring Plan:Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (Phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (“NIH Policy for
Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).Investigators
should seek guidance from their institutions, on issues related to
institutional policies and local institutional review board (IRB) rules, as
well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide
Association Studies (GWAS):NIH is interested in advancing genome-wide association
studies (GWAS) to identify common genetic factors that influence health and
disease through a centralized GWAS data repository. For the purposes of this
policy, a genome-wide association study is defined as any study of genetic
variation across the entire human genome that is designed to identify genetic
associations with observable traits (such as blood pressure or weight), or the
presence or absence of a disease or condition. All applications, regardless of
the amount requested, proposing a genome-wide association study are expected to
provide a plan for submission of GWAS data to the NIH-designated GWAS data
repository, or provide an appropriate explanation why submission to the
repository is not possible. Data repository management (submission and access)
is governed by the Policy for Sharing of Data Obtained in NIH Supported or
Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088.
For additional information, see http://grants.nih.gov/grants/gwas/

Sharing of Model Organisms:NIH is committed to support efforts that encourage
sharing of important research resources including the sharing of model
organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh-Dole Act (see the NIH
Grants Policy Statement. Beginning October 1, 2004, all investigators
submitting an NIH application or contract proposal are expected to include in
the application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.

Access to Research Data through the Freedom of
Information Act:The Office of Management and Budget (OMB) Circular
A-110 has been revised to provide access to research data through the Freedom
of Information Act (FOIA) under some circumstances. Data that are: (1) first
produced in a project that is supported in whole or in part with Federal funds;
and (2) cited publicly and officially by a Federal agency in support of an
action that has the force and effect of law (i.e., a regulation) may be
accessed through FOIA. It is important for applicants to understand the basic
scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this funding opportunity in a
public archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the application.
In addition, applicants should think about how to structure informed consent
statements and other human subjects procedures given the potential for wider
use of data collected under this award.

Inclusion of Women And Minorities in Clinical Research:It is the policy of the NIH that women and members of
minority groups and their sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification is
provided indicating that inclusion is inappropriate with respect to the health
of the subjects or the purpose of the research. This policy results from the
NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All
investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the SF424 (R&R) application; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a) all
applications or proposals and/or protocols must provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting analyses,
as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:The NIH maintains a policy that children (i.e.,
individuals under the age of 21) must be included in all clinical research,
conducted or supported by the NIH, unless there are scientific and ethical
reasons not to include them. All investigators proposing research involving
human subjects should read the "NIH Policy and Guidelines" on the
inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:NIH policy requires education on the protection of
human subject participants for all investigators submitting NIH applications
for research involving human subjects and individuals designated as key
personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):Criteria for Federal funding of research on hESCs can
be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators
funded by the NIH must submit or have submitted for them to the National
Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an
electronic version of their final, peer-reviewed manuscripts upon acceptance
for publication, to be made publicly available no later than 12 months after
the official date of publication. The NIH Public Access Policy is
available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html).For more information, see the Public
Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:The Department of Health and Human Services (HHS)
issued final modification to the "Standards for Privacy of Individually
Identifiable Health Information", the "Privacy Rule", on August
14, 2002. The Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the protection
of individually identifiable health information, and is administered and
enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of
the Privacy Rule reside with the researcher and his/her institution. The OCR
website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text and
a set of decision tools on "Am I a covered entity?" Information on
the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs
in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding
must be self-contained within specified page limitations. For publications
listed in the appendix and/or Progress report, Internet addresses (URLs) or
PubMed Central (PMC) submission identification numbers must be used for
publicly accessible on-line journal articles. Publicly accessible on-line
journal articles or PMC articles/manuscripts accepted for publication that are
directly relevant to the project may be included only as URLs or PMC
submission identification numbers accompanying the full reference in either
the Bibliography & References Cited section, the Progress Report
Publication List section, or the Biographical Sketch section of the NIH grant
application. A URL or PMC submission identification number citation may be
repeated in each of these sections as appropriate. There is no limit to the
number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This FOA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority
and Regulations:
This program is described in
the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and
45 CFR Parts 74 and 92. All awards are subject to the terms and conditions,
cost principles, and other considerations described in the NIH Grants
Policy Statement.

The PHS strongly
encourages all grant recipients to provide a smoke-free workplace and
discourage the use of all tobacco products. In addition, Public Law 103-227,
the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in
some cases, any portion of a facility) in which regular or routine education,
library, day care, health care, or early childhood development services are
provided to children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.

Loan Repayment
Programs:NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications
are encouraged. The periods of career award and LRP award may overlap providing
the LRP recipient with the required commitment of time and effort, as LRP
awardees must commit at least 50% of their time (at least 20 hours per week
based on a 40 hour week) for two years to the research. For further
information, please see: http://www.lrp.nih.gov/.